A Phase 4 interventional study of Ketoconazole 2% Shampoo and Placebo Shampoo in Pityriasis Versicolor, sponsored by Fakultas Kedokteran Universitas Indonesia. Not yet recruiting. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Fakultas Kedokteran Universitas Indonesia · Phase 4, Interventional, and Treatment
The goal of this clinical study is to find out whether using ketoconazole 2% shampoo for seven days works better than using it for three days in treating pityriasis versicolor. The study will also evaluate the safety of both treatment durations.
The main questions this study aims to answer are:
This study is a double-blind randomized clinical trial designed to compare the effectiveness and safety of two different treatment durations of ketoconazole 2% shampoo in patients with pityriasis versicolor, a common superficial fungal infection caused by Malassezia species, particularly prevalent in tropical climates.
The study is conducted in outpatient dermatology clinics in Indonesia, where high temperature and humidity may contribute to persistent or suboptimal treatment responses with standard short-course topical therapy. Current clinical practice commonly recommends a three-day regimen of ketoconazole 2% shampoo; however, longer exposure may be necessary to achieve adequate antifungal activity under tropical conditions. This trial evaluates whether extending treatment to seven days provides superior therapeutic benefit while maintaining an acceptable safety profile.
Eligible participants with a confirmed diagnosis of pityriasis versicolor are randomly assigned to receive ketoconazole 2% shampoo for either three consecutive days or seven consecutive days. Randomization is performed using a concealed allocation sequence. Both participants and investigators are blinded to treatment allocation. The shampoo formulation, packaging, and labeling are identical in both groups to maintain blinding throughout the study.
Participants are instructed to apply the shampoo to affected areas or the entire body, as indicated, once daily according to the assigned regimen. The shampoo is left on the skin for a standardized duration before rinsing. No additional antifungal treatments are permitted during the study period.
Clinical and mycological evaluations are performed at baseline and during follow-up visits. Mycological assessment is conducted using direct microscopic examination of skin scrapings. Clinical evaluation includes physical examination of skin lesions and documentation of treatment response. Dermoscopic examination is performed as supportive data to assess morphological changes before and after therapy.
Safety monitoring is conducted throughout the study. Participants are instructed to report any adverse skin reactions, including irritation, burning sensation, pruritus, or signs suggestive of contact dermatitis. All adverse events are recorded and managed according to predefined safety procedures.
Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive ketoconazole 2% shampoo, applied once daily to affected skin areas or the whole body, as instructed. The shampoo is left on the skin for 5 minutes before rinsing. Treatment is administered for seven consecutive days.
Drug: Ketoconazole 2% Shampoo
Participants receive ketoconazole 2% shampoo, applied once daily for three consecutive days, followed by a placebo shampoo once daily for four additional days, resulting in a total treatment duration of seven days. The shampoo is left on the skin for 5 minutes before rinsing. The application method is identical in both arms.
Drug: Ketoconazole 2% Shampoo · Drug: Placebo Shampoo
Ketoconazole 2% shampoo is a topical antifungal formulation used for the treatment of pityriasis versicolor. It exerts its antifungal effect by inhibiting ergosterol synthesis in Malassezia species.
Placebo shampoo is a vehicle formulation identical in appearance, texture, and odor to ketoconazole shampoo but without the active antifungal ingredient. It is used to maintain blinding during the study period.
Proportion of participants with negative KOH microscopy
Mycological cure is defined as a negative result on direct microscopic examination of skin scrapings using potassium hydroxide (KOH) preparation after completion of treatment.
Time frame: Day 7 after initiation of treatment
Proportion of participants with resolution of fine scaling
Clinical improvement is assessed based on the resolution of fine scaling associated with pityriasis versicolor on physical examination.
Time frame: Day 7 after initiation of treatment
Number of participants with treatment-related local adverse events
Adverse events include any local skin reactions such as pruritus, burning sensation, erythema, or contact dermatitis reported or observed during the treatment period.
Time frame: During the 7-day treatment period
Proportion of participants with improvement in dermoscopic scaling
Improvement is defined as the reduction or absence of fine scaling on dermoscopic examination at Day 7 compared with baseline.
Time frame: During the 7-day treatment period
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared with other researchers. All data collected in this study will be used solely for the purposes of the study protocol and related publications, and will be reported only in aggregate form to protect participant confidentiality.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Tinea Versicolor
Fakultas Kedokteran Universitas Indonesia